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As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas Pharmaceuticals Ltd. for its proposed denosumab biosimilar.  In the CSR, data was presente...

On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following:

Sandoz’s Wyost® and Jubbonti®, the first biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) to be PBS listed;
Celltrion’s Steqeyma®...

On 1 August 2025, the Korea Biomedical Review reported that Boryung launched Samsung Bioepis’ denosumab biosimilar (Xbryk™) in the Korean market, following its regulatory approval in May 2025.  Xbryk™ is a biosimilar to Amgen’s Xgeva® and is approved to prevent skeletal com...

On 30 July 2025, Sandoz and Evotec announced that they have signed a non-binding term sheet relating to Sandoz’s potential acquisition of Just-Evotec Biologics EU and its J.POD® biologics manufacturing facility in Toulouse, France.  Under the proposed arrangement, Sandoz wo...

On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered:

Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg), for all reference indications...

On 29 July 2025, in a report to its shareholders, Celltrion announced that it has been designated as the preferred bidder for an undisclosed large-scale cGMP US manufacturing plant owned by a global pharmaceutical company.  Celltrion is expecting to complete the acquisition...

On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in India.

One of Roche’s patents in suit, IN464...

On 25 July 2025, Ono Pharmaceutical Co announced the additional approval by the Taiwan Food and Drug Administration (TFDA) of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as intravenous infusion for first-line treatment of adult patients with unresectable or...

On 25 July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its July meeting, with positive opinions for the following denosumab, aflibercept and ustekinumab biosimilars:

Shanghai Henlius’ Bildyos...